Human Factors: MB’s Main Takeaways

Users are unpredictable, and that’s the point. Doing risk and use-risk analyses, you need to consider all the ways a user could behave.

Physical and sensory questions. What will the user see and hear? What manual dexterity and strength are required? Can they reach everything in the proper order?

The “correct answer” may not be the correct answer. Paraphrasing, “Pistol grips for laparoscopic surgery are ergonomically incorrect. But if I change it, physicians may balk because that’s how they were trained to use it!”

Perception and cognitive questions. What confirmation can we give the user to say they did it correctly?

Guidance documents. MB shared four guidance documents (two from IEC, one from MRHA, one from FDA) and why each is important.

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